Cleared Traditional

K922914 - EMIT 2000 PROCAINAMIDE CALIBRATORS

K922914 is the FDA 510(k) clearance for EMIT 2000 PROCAINAMIDE CALIBRATORS by Syva Co.. It is a Class 2 Toxicology device (product code LAR) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K922914 · Syva Co. · Toxicology device
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Optimized for regulatory review, auditing and printing
Aug 1992
Decision
68d
Days
Class 2
Risk

K922914 is an FDA 510(k) clearance for the EMIT 2000 PROCAINAMIDE CALIBRATORS. Classified as Enzyme Immunoassay, Procainamide (product code LAR), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on August 24, 1992 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Syva Co. devices

Submission Details

510(k) Number K922914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1992
Decision Date August 24, 1992
Days to Decision 68 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 87d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LAR Enzyme Immunoassay, Procainamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - LAR Enzyme Immunoassay, Procainamide

All 22
Devices cleared under the same product code (LAR) and FDA review panel - the closest regulatory comparables to K922914.
ABBOTT AXSM PROCAINAMIDE ASSAY
K955444 · Abbott Laboratories · Apr 1996
OPUS PROCAINAMIDE
K951434 · Behring Diagnostics, Inc. · Jul 1995
COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR
K942847 · Roche Diagnostic Systems, Inc. · Dec 1994
EASY-TEST EMIT PROCAINAMIDE (PROC) #16648
K873350 · Em Diagnostic Systems, Inc. · Sep 1987
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.
K860141 · American Dade · Feb 1986
COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR
K852320 · Roche Diagnostic Systems, Inc. · Jul 1985